IMROZ
Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma (IMROZ)
Phase 3N = 446NCT03319667
- Population
- Newly diagnosed multiple myeloma, aged 18 to 80 years, ineligible for transplantation.
- Design
- International, open-label phase 3 trial: patients 18 to 80 years of age with newly diagnosed myeloma ineligible for transplantation were randomly assigned 3:2 to isatuximab plus VRd or VRd alone. The primary end point was progression-free survival; key secondary end points included complete response or better and MRD-negative status in patients with a complete response. 446 patients were randomised (the registry lists 475).
- Primary endpoint
- PFS
- Arms
- Isatuximab + VRd (experimental): Isatuximab with bortezomib, lenalidomide and dexamethasone
- VRd (control): Bortezomib, lenalidomide and dexamethasone
- People
- Facon T
PFSHR 0.6Δ 60-month PFS+18 pointsΔ ≥CR rate+10.6 pointsΔ MRD+14.6 points
Show the numbers
| Endpoint | Analysis | Isatuximab + VRd | VRd | Effect |
|---|---|---|---|---|
| PFSRandomised patients (446) | primarymedian follow-up 59.7 monthsFacon 2024 | 63.2% at 5 y | 45.2% at 5 y | HR 0.6P<0.001The hazard ratio of 0.60 is reported with a 98.5% confidence interval of 0.41 to 0.88. |
| ≥CR rateRandomised patients (446) | primaryFacon 2024 | 74.7% | 64.1% | P=0.01 |
| MRDRandomised patients (446) | primaryFacon 2024 | 55.5% | 40.9% | P=0.003MRD-negative status in patients with a complete response. |
| Endpoint | Analysis | Isatuximab + VRd | VRd | Effect |
|---|---|---|---|---|
| PFSRandomised patients (446) | primarymedian follow-up 59.7 monthsFacon 2024 | 63.2% at 5 y | 45.2% at 5 y | HR 0.6P<0.001The hazard ratio of 0.60 is reported with a 98.5% confidence interval of 0.41 to 0.88. |
| ≥CR rateRandomised patients (446) | primaryFacon 2024 | 74.7% | 64.1% | P=0.01 |
| MRDRandomised patients (446) | primaryFacon 2024 | 55.5% | 40.9% | P=0.003MRD-negative status in patients with a complete response. |